PATCHASSIST LARGE— 510(k) K103269

Substantially Equivalent

Polytouch Medical, Ltd.

FDA 510(k) clearance K103269 for PATCHASSIST LARGE, Substantially Equivalent on 2010-11-23. Applicant: Polytouch Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Polytouch Medical, Ltd.
Product code: Code ORQ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2010-11-04
Decision date: 2010-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Providence, RI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.